Job
Description
A Day in the Life SW Risk Management Engineer A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and other relevant industry standards during product development and changes. Participate on cross-functional teams to develop product risk management file for software and non software products (risk management plan, risk assessments, Hazard Analysis, DFMEA, and risk management report). Strong in software risk management, software design and development, software verification and validation activities Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Provide Quality support to facilitate resolution of product complaints and/or safety issues Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Good verbal and written communication skills Minimum Qualification B E or B.Tech in Computer science/Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt
